After duodenoscopes caused hospital outbreaks that affected hundreds of patients years ago, the Food and Drug Administration (FDA) advised hospitals to switch to the type of device with disposable parts. These instruments, however, have also recently been cited by the agency as having defects, as reported by The New York Times.
The duodenoscope is a long, snake-like camera used to examine the pancreas and bile ducts. It is put into the upper section of the small intestine through the mouth.
These devices are used in around 500,000 US operations a year, but they are hard to clean and may house E. coli.
Reported Complaints
In order to protect the camera at the end of its duodenoscopes, Olympus Medical Systems creates disposable tip covers designed like small thimbles.
The FDA notes that in dozens of surgeries, the tips have come off in patients' mouths or stomachs. Some of these parts had sharp edges that injured victims, causing internal bleeding. The FDA even received complaints of lacerations that led to major bleeding episodes in certain cases.
Meanwhile, in May 2021, a case was also reported in which a doctor was withdrawing a scope from a patient's stomach when the soft tip cover fell off inside their abdomen. The report said, "It was decided to allow the tip cover to pass naturally through the GI system than to subject the patient to further anesthesia time in attempting to remove it."
Issued Warning
Late last year, the FDA inspected Tokyo's Olympus Medical Systems factory. This month, the agency informed the firm that the inspector detected adulterated or faulty duodenoscope covers and bronchoscope suction valves used to check the lungs.
Olympus' study found that 160 complaints regarding duodenoscope caps breaking off were above the expected numbers for this sort of complaint, as per FDA.
The FDA has been in contact with the firm prior to this warning, and the agency has said that the company's replies have been "not adequate." The FDA further disagrees with the company's assessment that the danger to patients is "low enough risk to not warrant further action at this time."
Jennifer Bannan, an Olympus spokeswoman, said the firm will further evaluate these actions and expand those efforts to alleviate the FDA's concerns.
Dr. Jeff Shuren, head of the FDA's Center for Devices and Radiological Health, released a statement in January detailing the issues at Olympus but noting the minimal risk of infection from improper cleaning of duodenoscopes.
He advised patients should examine the advantages and dangers before canceling or delaying operations.
There were additional issues, such as creases and air bubbles in the sealed packing of single-use suction valves for bronchoscopes, that were brought to Olympus' attention in the most recent warning letter. The FDA stated the valves' irregularities created sterility issues.
The agency also voiced worry over fractured duodenoscope caps that malfunctioned and injured users.
Other businesses make scopes with disposable components, including entirely disposable duodenoscopes, which the FDA certified in 2019. It is unclear at this time whether hospitals and patients must decide on such options.
